The DePuy Pinnacle hip replacement system has recently gone under scrutiny by many experts. The appraisal became intense after the FDA found few benefits for metal to metal hip replacements. Federal regulators announced that a two-day expert review panel will convene in response to increasing concerns over metal hip implants.

 

According to a Reuters article, the FDA meeting occurred in June 27-28. Scientists, researchers, patients and doctors were asked to weigh in on whether metal hip implants need new testing standards and review requirements before they receive market approval. The FDA goes on about the meeting saying “We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendation.”

 

The United States is not the only country to review the safety of the DePuy Pinnacle and other metal-on-metal hip replacement systems. In May 9, 2012, Health Canada, the Canadian national health regulatory agency, issued a warning for patients to be aware of metal hip replacement problems and adverse effects. In February 2012, an investigation by the British Medical Journal advised that patients should be monitored annually for signs of metallosis, or metal poisoning, for as long as they had a metal hip implant. On March 2012, a study published in The Lancet medical journal concluded that metal-on-metal hips should not be used at all due to serious issues with the safety of the implants.

 

Other analysts claimed that internal DePuy documents reviewed by the British Medical Journal showed that as early as 2005, DePuy was already aware of the damage that could be done to patients by metal-on metal-implants.  E-mails reviewed by the British Medical Journal showed that Japanese surgeons warned DePuy in 2009 that metal debris from the Pinnacle was harming patients.  And in 2010, a senior DePuy executive said in an internal document that he was “concerned” about problems with the metal-on-metal Pinnacle and similar implants. “I feel the problem is emerging as more serious than first thought,” he wrote. The impact of these documents becoming public knowledge is yet to felt as DePuy still continues to market these types of hip implants.

 

URL References:

bmj.com/content/344/bmj.e1410